Neo-TACE-HAIC for BCLC B Stage HCC (NeoconceptB)

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Surgery alone; Procedure: neo-TACE-HAIC+Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04424043

B2020-127

Details and patient eligibility

About

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age 18-75 years;

  • BCLC B stage and tumor number <=4;
  • Patients with resectable primary hepatocellular carcinoma;
  • Child-Pugh A or B (7 score) liver function;
  • The volume of residual liver more than 30%

Exclusion criteria

• • With unresectable HCC

  • Pregnant woman or sucking period;
  • With other malignant cancer;
  • Received anti-HCC therapy before this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

neo-TACE-HAIC with surgery

Experimental group

Description:

transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection

Treatment:

Procedure: neo-TACE-HAIC+Surgery

surgery alone

Active Comparator group

Description:

hepatic resection remove the liver tumors

Treatment:

Procedure: Surgery alone